Premphase NDC 0046-2575

NDC codes

FDA NDC Directory

Product NDC (as listed)0046-2575Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00046-2575Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0046-2575-12	00046257512	1 BLISTER PACK in 1 CARTON (0046-2575-12) / 1 KIT in 1 BLISTER PACKMarketed from Mar 1, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Premphase
Generic name (nonproprietary): conjugated estrogens and medroxyprogesterone acetate
Dosage form: Kit
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020527
Marketing start: Mar 1, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 0046-2575_cce04608-5f9f-434f-b4ab-d5c19847095aSPL ID cce04608-5f9f-434f-b4ab-d5c19847095aSPL set ID fd0c0836-5d23-2183-da81-9dc7f4287052RxCUI 150840, 310197, 1000351, 1000352, 1000355, 1000356, 1000395, 1000398, 1000486, 1000487, 1000490, 1000491, 1000496, 1000497, 1000499, 1000500UNII C2QI4IOI2G, IU5QR144QX

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400046257512 followed by a unit qualifier and the quantity

Package 00046-2575-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a woman with a uterus for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Prevention of Postmenopausal Osteoporosis ( 1.3 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause 1.3 Prevention of Postmenopausal Osteoporosis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020527

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020527
Product	Strength	Form · route	Labeler	Product NDC
Premproconjugated estrogens and medroxyprogesterone acetate	Estrogens, Conjugated .625 mg/1; Medroxyprogesterone acetate 5 mg/1	Tablet, Sugar coatedOral	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1108
Premproconjugated estrogens and medroxyprogesterone acetate	Estrogens, Conjugated .45 mg/1; Medroxyprogesterone acetate 1.5 mg/1	Tablet, Sugar coatedOral	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1106
Premproconjugated estrogens and medroxyprogesterone acetate	Estrogens, Conjugated .625 mg/1; Medroxyprogesterone acetate 2.5 mg/1	Tablet, Sugar coatedOral	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1107
Premproconjugated estrogens and medroxyprogesterone acetate	Estrogens, Conjugated .3 mg/1; Medroxyprogesterone acetate 1.5 mg/1	Tablet, Sugar coatedOral	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0046-1105