NDC 0005-1971-01 - PREVNAR 13

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0005-1971
Requested NDC: 0005-1971-01
Package NDCs from labels: 0005-1971-01, 0005-1971-02, 0005-1971-05
Manufacturer: Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Pfizer Manufacturing Belgium NV | Pfizer Inc
Effective date: 2025-02-04
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PREVNAR 13	Wyeth Pharmaceutical Division of Wyeth Holdings LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Pfizer Manufacturing Belgium NV \| Pfizer Inc	2025-02-04	VACCINE LABEL
PREVNAR 13 - A-S Medication Solutions	A-S Medication Solutions	2024-05-24	VACCINE LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0005-1971-02	2024-01-30	C162847	48780-1	1030e365-5925-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]) Suspension for intramuscular injection Initial U.S. Approval: 2010
0005-1971-05	2024-01-30	C162847	48780-1	1030e365-5925-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]) Suspension for intramuscular injection Initial U.S. Approval: 2010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0005-1971	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS LLC]	44	Legacy NDC	20250206_5d49181b-b974-a5da-3b38-12a3a87bb96b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0005-1971-01	ML - Milliliter	0005-1971	2e469a17-6a30-4273-b3b6-470fad6365f4	1	2013-02-13
0005-1971-02	ML - Milliliter	0005-1971	412d9b5b-9cb2-4f8c-a73c-83997f992502	1	2013-02-13
0005-1971-05	ML - Milliliter	0005-1971	9d55d319-903d-43a6-ba5b-3f6410a5c309	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	54EC0SE5PZ	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	SK54I0S386	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	XK87D9J012	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	B970MQT365	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	2E1M7F958B	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	25N8E57V6T	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	2VF3V7175U	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	TGJ6YZC4W7	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	5SKG37872O	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	Z9HK08690W	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	4M543JVT7G	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	0K0S2P98ZJ	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE INGREDIENT	5Q768OY0GI	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	54EC0SE5PZ	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	SK54I0S386	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	XK87D9J012	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	B970MQT365	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	2E1M7F958B	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	25N8E57V6T	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	2VF3V7175U	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	TGJ6YZC4W7	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	5SKG37872O	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	Z9HK08690W	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	4M543JVT7G	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	0K0S2P98ZJ	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN	ACTIVE MOIETY	5Q768OY0GI	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
ALUMINUM PHOSPHATE	INACTIVE INGREDIENT	F92V3S521O	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREVNAR 13 (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.]	24

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rohto Max Strength	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	e4b49550-1ca3-4bd7-854d-409b53fa5e26	2026-08-20	Warnings	Exact identifier unii: 6OZP39ZG8H
Droptics Dry Eye Relief	CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80	Droptics LLC	29d7614b-f4b7-48e2-97c5-d1bff27731d2	2026-07-22	Warnings	Exact identifier unii: 6OZP39ZG8H
Gelfos-M	ALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONE	Masaem Company	56b9a769-08fb-738f-e063-6294a90a9eb2	2026-07-16	Warnings	Exact identifier unii: F92V3S521O
Rohto Cool Relief	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30	2026-06-19	Warnings	Exact identifier unii: 6OZP39ZG8H
Refresh Optive Mega-3 PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	326cb5d6-c784-404f-9a13-6d69262dda6e	2026-03-01	Warnings	Exact identifier unii: 6OZP39ZG8H
Aluminium Phosphoricum	ALUMINIUM PHOSPHORICUM	Hahnemann Laboratories, INC.	003ea3bc-9e9a-00ab-e063-6394a90aac24	2023-07-11		Exact identifier unii: F92V3S521O
Refresh Digital PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	97e83e68-6374-4df4-93f6-d707fc32748d	2022-11-28	Warnings	Exact identifier unii: 6OZP39ZG8H
Refresh Digital	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81	2022-11-28	Warnings	Exact identifier unii: 6OZP39ZG8H
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	2022-09-15	Warnings	Exact identifier unii: 6OZP39ZG8H
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80	Allergan, Inc.	aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0	2022-09-01	Warnings	Exact identifier unii: 6OZP39ZG8H
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier unii: 6OZP39ZG8H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.